Lung Imaging of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)

NCT02978144 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: AAAR04171R01HL131960-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective interventional study examining the use of Annexin - a radioactive tracer, in assessing lung damage in healthy volunteers, healthy volunteers actively smoking, and patients with moderate and severe chronic obstructive pulmonary disease (COPD). All study participants will undergo a CT scan, pulmonary testing, and blood test. The study procedures are done in one day. The aim of this study is to determine if Annexin can be used as a marker to detect lung injury early on and aid in the future diagnosis of COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Phase 2

Outcome Measures

Primary Outcomes (1)

• Mean AxV-128/Tc Uptake

  Mean ± standard deviation (SD) for values for uptake of AxV-128/Tc for individual lobes and for lungs will be determined for each COPD group and compared using unpaired t-test for values with Gaussian distribution and Mann Whitney (Wilcoxon rank) test for continuous variables without normal distribution.

  At first visit (Day 1) and if available, at up to 18 months from the initial scan

Study Arms (1)

All Participants

EXPERIMENTAL

All study participants will be administered Annexin (study drug also known as 99mTc-Annexin V-128 (AxV-128/Tc)) intravenously (IV) followed by SPECT-CT imaging scan.

Drug: AxV-128/Tc

Interventions

AxV-128/Tc DRUG

Study drug 99mTc-Annexin V-128 (AxV-128/Tc) is administered intravenously prior to SPECT/CT imaging.

All Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage II, forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) \< 0.7 and FEV1 50-79% predicted
• Patients with severe COPD: GOLD Stage III-IV, FEV1/FVC \< 0.7 and FEV1 \< 50% predicted
• Healthy controls who are currently smoking (\> 10 pack years) with normal spirometry (FEV1 \> 80% and FEV1/FVC \> 70%)
• Healthy controls who never smoked (less than 100 lifetime cigarettes) with normal spirometry (FEV1 \> 80% and FEV1/FVC \> 70%)

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gebhard Wagener, MD
• Organization: Columbia University

gw72@cumc.columbia.edu

(212) 305-6494

Study Officials

• Gebhard Wagener, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study participants will receive study drug Annexin.

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: June 15, 2017
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2025-09

Locations

US (1)